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Completed

NCT Number: NCT00656942

Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain

The MGH Center for Translational Pain Research is seeking patients with chronic pain for a research study. The study is looking at the effect of opioid (narcotic) pain medicines on pain sensation, threshold and tolerance.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MGH Center for Translational Pain Center

Boston, Massachusetts, 02114, United States

About this study

The study consists of one visit, in which an interview, physical exam, lab work (urine test) and sensory testing will be done. The testing (Quantitative Sensory Testing) is noninvasive (no needles) and involves heat and cold stimulation. Compensation and some parking reimbursement provided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

a. Inclusion/exclusion criteria

Inclusion criteria

for the group with chronic pain on chronic treatment with opioids:

  • Subject has chronic pain and is on stable chronic opioid treatment (morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for chronic pain for at least one month. We consider stable treatment if no change in the type and amount of daily opioid treatment for one month. Only patients with minimal daily opioid dose of at least 30 mg morphine equianalgesic dose will be included.
  • Subject is age 18 to 65 years.

Inclusion criteria

for the group with chronic pain on chronic treatment with non-opioids (currently not recruiting):

  • Subject has pain and is on stable chronic non-opioid treatment for chronic pain for at least one month.
  • Subject is age 18 to 65 years.

Inclusion criteria

for the group of opioid-naive healthy volunteers without chronic pain (currently not recruiting):

  • Subject is opioid naive meaning he/she did not receive chronic opioid treatment in the past or present, and did not receive acute treatment with opioids in the last 1 month
  • Subject does not have pain
  • Subject is age 18 to 65 years.

Exclusion criteria

for all groups:

  • Subject has lost tactile sensation in the sites for QST testing (upper extremities)
  • Subject has scar tissue or acute injury in the skin areas for QST testing (upper extremities)
  • Subject has neurological disease or a medical condition causing peripheral polyneuropathy and sensory changes (including but not limited to diabetes, alcoholism, AIDS, thyroid disease, liver or kidney disorders). It is the presence of neuropathy, not the causative disease itself, that is the exclusion criteria.
  • Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months; peripheral neurolytic block within two-months; injection therapy for pain within four-weeks; sympathetic block within six months.
  • Subject has litigation pending relative to their chronic pain.
  • Subject has major psychiatric disorder (major depression disorder; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); any known history of these conditions will exclude participation.
  • Subject has used illicit drugs within past 6 months.
  • Subject is pregnant

Treatment and study plan

Quantitative Sensory Testing (QST)

Device

QST consists of a series of heat and cold stimulation tests.

Primary outcomes

  1. Response to warm/cold temperature

    Time frame: 2 hours

    Responses to warm/cold temperatures will be recorded by the Quantitative Sensory Testing device (QST).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2013
Study completion
2018
First posted
Apr 14, 2008
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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